Data / Medical devices / Needle, Hypodermic, Single Lumen / Mexico
FDA-registered makers of Needle, Hypodermic, Single Lumen in Mexico: 17 establishments
17 establishments in Mexico are registered with the FDA to make Needle, Hypodermic, Single Lumen (product code FMI). 9 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Needle, Hypodermic, Single Lumen
- Product code
- FMI
- Country
- Mexico
Makers of Needle, Hypodermic, Single Lumen in Mexico
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Arrow Internacional de Chihuahua S.A. de C.V. | Chihuahua, Mexico | Exporter to the US, Manufacturer, Repackager or relabeler | 14 | July 25, 2023 | 0 | 0 | 0 | api.fda.gov |
| BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. S.A. de C.V. | NOGALES Sonora, Mexico | Manufacturer | 4 | May 27, 2016 | 0 | 0 | 0 | api.fda.gov |
| ICU Medical Healthcare Manufacturing S.A. de C.V. | Tijuana, B.C. C.P. Baja California, Mexico | Manufacturer | 3 | November 1, 2007 | 0 | 0 | 0 | api.fda.gov |
| ICU Medical Healthcare Manufacturing S.A. de C.V. | APODACA Nuevo Leon, Mexico | Manufacturer | 3 | August 2, 2007 | 0 | 0 | 0 | api.fda.gov |
| Bard Reynosa S.A. De C.V. | REYNOSA Tamaulipas, Mexico | Contract manufacturer, Repackager or relabeler | 1 | December 18, 1986 | 0 | 0 | 0 | api.fda.gov |
| Becton Dickinson De Mexico | CUAUTITLAN, IZCALLI Queretaro, Mexico | Manufacturer | 1 | July 19, 2002 | 0 | 0 | 0 | api.fda.gov |
| Bemis De Mexico, S.A. DE C.V. | Cienega De Flores Nuevo Leon, Mexico | Manufacturer | 1 | February 14, 1997 | 0 | 0 | 0 | api.fda.gov |
| Cardinal Health (Kenmex Medical Specialties) | TIJUANA Baja California, Mexico | Manufacturer | 1 | October 8, 1991 | 0 | 0 | 0 | api.fda.gov |
| ICU MEDICAL DE MEXICO, S. de R.L. de C.V. | ENSENADA, Baja California, Mexico | Contract manufacturer, Manufacturer, Repackager or relabeler | 1 | February 16, 1994 | 0 | 0 | 0 | api.fda.gov |
| Covidien | TIJUANA, B.C. Mexico, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flextronics Manufacturing Juarez S. DE R.L. DE C.V. | Juarez Chihuahua, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Integra Biotechnical, SA de CV | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Martech Medical Products S. De RL. De CV. | MEXICALI Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medimexico, S. De R.L. De C.V. | TIJUANA Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| NPA de México S. de R.L. de C.V. | TIJUANA Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Polimeros Formula de Tecate S.A de C.V | Tecate Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RR Donnelley Global Turnkey Solutions | Juarez Chihuahua, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.